我们的质量体系
在Alleva Medical，质量是义务。 Alleva Medical设施已通过认证，符合北美，欧洲，日本和中国的国际质量标准。 我们已通过FDA和CFDA注册，并获得ISO 13485/9001认证。 我们的工厂已获得制造CE，GS，FCC，UL，ETL和PSE电气产品的认证。 我们的制造过程将满足欧洲RoHS，WEEE和REACH要求。
Alleva Medical Quality Statement:
- Providing products that are safe and effective, and meet or even exceed our customers' expectations and regulatory requirements.
- Upholding the integrity of our people, products, and processes.
- Maintaining full conformance to our quality system and applicable regulatory requirements.
- Driving continuous improvement through technological and operational excellence.
A representative list of our testing equipments includes:
- Tensile Test, Pull Test, and Leakage Test
- Digital Light Level Meter
- Coordinate Measuring Machine
- Automatic Optical Inspection
- Frequency Spectrum Analyzer, Faraday Cage,
- Drop Test Platform
- Transportation Simulation
- Aging Test, Temperature-Cycle Test Oven
- Class 100 Clean Bench for Microbiology and Bioburden Test
